Vaginal appliance



Oct, 21, 1958 v. INDELICATO VAGINAL APPLIANCE Filed May 27. 1955 v INVENTOR. I/INCENT [N DEL/CATO.

ATTORNEYS.

United States Patent VAGINAL APPLIANCE Vincent Indelicato, New York, N. Y.

Application May 27, 1955, Serial No. 511,473 10 Claims. Cl. 128-430 mitting air in to the outer member and for retaining the.

air'in the outer member after it is inflated. Such ap-' pliances are formed from relatively heavy rubber and employ relatively bulky and rigid valves. For these reasons the appliances are relatively expensive and form a relatively rigid obstruction in the vagina. Accordingly] these appliances are considered too expensive to be disposable after use and are not always comfortable for the j wearer 01 01 other reasons.

In addition, with the prior art types of cnstruction, it, has been difficult to insert and inflate the appliance and For example, if

then to remove the inflating device. the construction is such that the appliance is first inserted in the vagina and then the inflating device isengaged with the valve, it has been diflicult to locate the valve and engage it with the inflating device. On the other hand, if the inflating device is engaged with the valve, 40

prior to inserting the appliance in the vagina andif the engagement is sufiiciently secure to prevent disengagement during the insertion process, it has been ditficult to disengage the inflating device from the appliance after it is inflated Without dislodging the appliance. This latter difficulty would be particularly serious if low air pressure were employed.

If it is desired merely to prevent the flow of fluids into the uterus, it is necessary to have only a firm contact between the outer wall of an imperforate appliance and the wall of the vagina and, therefore, in this case, the air pressure after the appliance is inflated may be relatively low. This is particularly true if the appliance is made of very thin, pliable rubber, such as latex rubber, which can readily conform to any irregular confining wall.

Furthermore, with low air pressures, it is possible to eliminate the usual mechanical valve and its objectionable features by making at least a portion of the member of a puncture-sealing rubber known as natural gum rubber. Such rubber is sold by the U. S. Rubber Co., New York, N. Y., for making medical stoppers for medicine containers and can be punctured by a small needle, e. g. a hypodermic needle, and after the needle is withdrawn, the puncture is sealed by the rubber. The seal is strong enough to withstand air pressures up to several pounds per square inch.

In accordance with my invention, a vaginal appliance for preventing the flow of fluids into the uterus comprises an inflatable member made of a thin, pliable material, preferably latex rubber, one portion of which is made of or is closed by a puncture-sealing material which preferably is pure natural gum rubber of the above- 2,856,920 Patented Oct. 21, 1958 mentioned type although other known types of solid puncture-sealing material may be employed. Such an appliance is easy to insert and inflate, is inexpensive enough to be disposable after use and is sufliciently soft and pliable that it does not form an uncomfortable obstruction. v

Accordingly, one object of my invention is to provide a vaginal appliance which is simple and inexpensive to make and which may be readily inserted and inflated.

A further object of my invention is to provide a vaginal appliance which is soft and pliable throughout and which, therefore, is not uncomfortable in use.

A further object of my invention is to provide a simple and reliable device for inserting and inflating the appliance of my invention.

Other objects of the invention will be apparent from the following detailed description of different embodiments of the invention which sets forth. the manner in which I now prefer to practice .the invention and from the accompanying drawings in which:

Fig. l is a cross-sectional, side elevation view of the,

Figs. .4. and 5 are cross-sectional, side elevation views of alternate forms of the appliance; and

' Fig. 6 is a cross-sectional side elevation view of a modi fied form of the inner member shown in Fig. 1.

The preferred embodiment of the invention shown in Fig. 1 comprises an inflatable, hollow outer member 10,

a resilient inner member 11 and an inflating member 12 of puncture-sealing material. The outer member 10 preferably is madeof thin latex or gum rubber and when inflated has the ring-shaped or toroidal-like form indicated in Fig. 1. The portion 13 of one wall of the 'memf ber 10 is secured to one face of the inner member 11,

such as by cement, and the opposite portion 14 of the opposite wall of the member 10 is secured in an annular recess inthe inflating member 12. The portion 14 may be ecured to the inflating member 12 by cement or it may be bonded thereto in any other desired mannenwhich will provide an air-tight seal between the portion 14Iand the member 12. The inflating member 12 is also secured to one face of the inner member 11 so that when 1 the member 10 is inflated the central portions'of the walls of the, member 10 are constricted,thereby produc.

ing the ring or toroidal-like shape shown in Fig. 1. The inner member 11 preferably is made of a relativ'ely soft rubber, such as latex rubber, and has air ducts 15 and 16 therein which extend from the face of the inner member 11 nearest the inflating member 12 to the interior of the member 10. I 'Said ducts 15 and 16 permit the passage of air from the inflating member 12 to the interior of the member 10.

The inflating member 12 is hollowand is provided with aneck portion 17 for purposes hereinafter described. .As mentioned above, inflating member 12 is made of puncture-sealing material and preferably is made r pure, natural, gum rubber of the type described above.

The preferred applicator for the appliance of the invention comprises an elongated tubular member 18 having a centrally disposed bore 19 therein. A hollow tube 20 is slidably mounted in the bore 19 of the member 18. The tube 20 has a hollow needle 21 attached thereto, the needle 21 being of relatively small diameter, e. g. 0.03 inch. Needle 21 has a pointed end 210 which, in the retracted position of the needle, is adjais an end view of the embodiment shown 'in' cent the bottom 22 of the cylindrical recess 23 in the end of the member 18, such recess 23 being co-axial of the bore 19 of the member 18. When the needle 21 is in the inflating position shown in Figure 1, the pointed end 21a is adjacent but below the top of the recess 23.

Inflating means in the form of a rubber bulb '24 is connected to one end of the tube and is movable therewith. A check valve 25 permits air to be drawn into the bulb 24 whenthe bulb 24 is expanded and causes the air to pass through the bores of the tube 20 and the needle 21 when the bulbis compressed. Needle retracting means in the form of a spring 26 acts between the member 18 and a shoulder 27 on the rigid member 28 which interconnects the bulb 24 and the tube 20 and urges the needle 21 towards its retracted position.

The applicator is also provided with releasable catch means 29 which is mounted on the member 28 and takes the form of a U-shaped resilient member having a projecting portion 30 which is engageable with a stop 31 mounted onthe member 18. Thus, when the needle 21 is moved to its inflating position shown in Fig. 1, it is retained in such position by the catch means 29. When the catch means 29 is depressed, the spring 26 moves the needle 21 into its retracted position.

Prior to inflation, the outer member 10 is flaccid and may be caused to assume the position shown in Fig. 3, Fig. 3 illustrating the configuration of the outer member 10 and the relative positions of the appliance and the applicator immediately prior to the insertion of the appliance into the vagina. However, prior to causing the outer member 10 to assume the position shown in Fig. 3, the appliance is placed on a relatively rigid surface with the portion 13 against such surface and with the neck portion 17 extending upwardly. The catch means 29 is released so that the needle 21 is in its retracted position. The end of the member 18 is then engaged with the neck portion 17 so that the neck portion 17 fits within the recess 23. The member 28 is pushed downwardly until the projecting portion 30 on the catch means 29 engages the stop 31, causing the pointed end 21a of the needle 21 to puncture the neck portion 17.

The appliance preferably is provided with the neck portion 17 and the member 18 preferably is provided with the recess 23 because such combination assists in retaining the appliance in engagement with the applicator during insertion of the appliance and, in addition, the walls of the recess 23 provide support for the inflating member 12 during the puncturing thereof by the pointed end 21a of the needle 21. If the inflating member 12 is unsupported during the puncturing step, the wall of the inflating member gives under pressure of the needle and makes it diflicult to puncture said wall with the needle.

Also, in addition to functioning as means for con stricting the walls of the outer member 10, the inner member 11 assists in the puncturing of the inflating member 12 by the needle 21. Thus, air duct 15 of the inner member 11 provides a recess for reception of the pointed end 21a of the 'needle 21 and prevents the pointed end 21a from puncturing the portion 13 of the wall of the outer member 10.

After the applicator has been engaged with the appliance and the needle 21 has punctured the inflating member 12, the outer member 10 is positioned as shown in Fig. 3 and the appliance is inserted into the vagina by means of the applicator After insertion of the appliance and before removing the applicator, the outer appliance provides a fluid-tight seal with the wall of the "vagina and prevents the entrance of the fluids into the uterus.

After the outer member 10 is properly inflated, the catch means 29 is released, causing the needle 21 to withdraw from the inflating member 12. It will be noted that during such withdrawal of the needle 21,

the appliance is held in place by the end of the applica- I tion without such neck portion.

tor so that the appliance is not dislodged during the removal of the needle 21. After the needle 21 has been withdrawn or retracted, the applicator is easily disengaged from the appliance and withdrawn from the vagina because the appliance is held on the applicator primarily by the friction between the inflating member 12 and the needle 21.

The inner member 11 and the inflating member 12 shown in Fig. 1 may also be made as an integral unit in the manner shown in Fig. 6. Thus, the inner member 35 shown in Fig. 6 comprises air ducts 15 and 16 and a neck portion 17a which functions in the same manner as the neck portion 17 shown in Figs. l-3. The portion 14 of the outer member 10 is received in recess 36 and is bonded thereto to provide an air-tight seal with the inner member 35.

Although as mentioned above, it is preferable that the inflating member be provided with a neck portion, it is also possible to construct the appliance of the inven- Such modified form of the appliance is shown in Fig. 4 and it will be seen from Fig. 4 that this modified form of the appliance differs from the form described in Figs. 1-3 primarily in the substitution of a disc-shaped inflating member 32 for the inflating member 12. In Fig. 4, the inflating member 32 is made from puncture-sealing material such as the aforesaid gum rubber and is bonded to the inner member 11a and to the portion 14a of the outer member 10a. When using this form of the appliance or the form illustrated in Fig. 5, the applicator shown in Fig. 1 would be modified by omission of the recess 23 and its surrounding wall structure. Thus, in its retracted position the pointed end 210! of the needle 21 would be withdrawn into the bore 19 of the member 18 and in its inflating position the pointed end 210 would extend beyond the end of the member 18.

If desired, the inner member 11 and the inflating member 12 may be made of the same material and therefore they may be constructed as one unit. Fig. 5 illustrates the form of the member 11a when it is modified to incorporate the inflating member 32 as an integral part thereof, such modified inner member being designated by the numeral 33. As shown in Fig. 5, the inner member 33 has air ducts 1S and 16 and has thin wall 34- over the end of air duct 15 which is punctured by the needle 21 during the insertion and inflation process.

It will be apparent from the above that the appliance of the invention is simple and inexpensive to make and in fact, is sufiiciently inexpensive to be disposable. Furthermore, because the outer member 10 is made of thin pliable material, it will conform to irregular contours and form a fluid-tight seal even with low inflating pressures. In addition, because the outer member 19 is highly elastic and inflatable, no fitting of the appliance is required.

The appliance is sufficiently flexible even though inflated to permit removal thereof by grasping the outer member 10 or the neck portion 17 or 17a with the fingers and withdrawing the appliance from the vagina. Alternatively, the outer member 10 can be punctured and deflated before removal or the appliance can be provided with known types of removal devices employed with similar appliances or catamenial devices.

Having thus described my invention with particular reference to the preferred form thereof and having shown and described certain modifications, it will be obvious to those skilled in the art to which the invention pertains, after understanding my invention, that various changes and other modifications may be made therein without departing from the spirit and scope of my invention, as defined by the claims appended thereto.

What is claimed as new and desired to be secured by Letters Patent is:

1. A vaginal appliance comprising an inflatable, hollow, outer member, a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and both of said first-mentioned walls being secured to said inner member for maintaining substantially a predetermined spacing between said first mentioned walls, and an inflating member of puncturesealing material secured in air-tight relationship to one of said inner and outer members.

2. A vaginal appliance comprising an inflatable, hollow, outer member, a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and both of said first-mentioned walls being secured to said inner member for maintaining substantially a predetermined spacing between said first mentioned walls, and an inflating member of puncture-sealing material secured in air-tight relationship to said inner member.

3. A vaginal appliance comprising an inflatable, hollow, outer member, a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and both of said first-mentioned walls being secured to said inner member for maintaining substantially a predetermined spacing between said first mentioned walls, said inner member having an air duct therein extending from one face thereof to the interior of said outer member, and an inflating member of puncture-sealing, gum

rubber secured in air-tight relationship to said inner member and covering such air duct.

4. A vaginal appliance comprising an inflatable, hollow outer member, and a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and both of said first-mentioned walls being secured to said inner member, and at least one face of said inner member being formed of puncturesealing, material.

5. A vaginal appliance comprising an inflatable, hollow outer member, and a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and both of said first-mentioned walls being secured to said inner member, said inner member having an air duct therein extending from adjacent one face thereof to the interior of said outer member, and at least said face of said inner member being formed of puncture-sealing, natural, gum rubber. 1

6. A vaginal appliance comprising an inflatable, hollow, outer member, a pliable inner member disposed between the walls of said outer member, the peripheral wall of said outer member in its inflated state being spaced from said inner member and one of said first-mentioned walls being secured to one face of said inner member, and an inflating member of puncture-sealing material secured to said outer member and having an air-tight bond with said outer member, said inflating member having a neck portion extending outwardly from said outer member for engaging an inflating device and said inflating member having an air passageway extending from the outer end of said neck to the interior of said outer member.

7. A vaginal appliance comprising an inflatable, hollow, ring-shaped, latex rubber, outer member, a rubber inner member disposed centrally of said outer member between the walls thereof, the outer diameter of said outer member in its inflated state being greater than the outer dimensions of said inner member and one of said walls being secured to one face of said inner member, said inner member having an air duct therein extending from the other face thereof to the interior of said outer member, and an inflating member of puncture sealing, gum rubber secured to said outer member and having an air-tight bond with said outer member, said inflating member having a neck portion extending outwardly from said outer member for engaging an inflating device and said inflating member having an air passageway extending from the outer end of said neck to said air duct.

8. A vaginal appliance comprising an inflatable, hollow, ring-shaped, latex rubber, outer member, a rubber, discshaped, inner member disposed centrally of said outer member between the walls thereof, the outer diameter of said outer member in its inflated state being greater than the outer diameter of said inner member and one of said walls being secured to one face of said inner member, said inner member having an air duct therein extending from the other face thereof to the sides thereof and hence to the interior of said outer member, and an inflating member of puncture-sealing, gum rubber secured to said inner and outer members and having an air-tight bond with said outer member, said inflating member having a neck portion extending outwardly from said outer member for engaging an inflating device and said inflating member being disposed over said other face of said inner member and having an air passageway extending from the outer end of said neck to said air duct.

9. A vaginal appliance comprising an air-tight hollow, inflatable member, said member having oppositely and centrally disposed portions of the walls thereof interconnected for maintaining said portions in predetermined relationship, said member in its inflated state having a peripheral wall spaced from and extending around said portions, said portions having an air passageway therebetween opening into the interior of said member between said portions and said peripheral wall and at least one of said portions being formed by a puncture-sealing material and said member being substantially impervious to fluids at all portions thereof within said peripheral wall.

10. A vaginal appliance comprising an air-tight, hollow, inflatable member, said member in its inflated state comprising a pair of oppositely disposed, fluid impervious, adjacent walls having an air passageway therebetween, said walls being interconnected for maintaining a predetermined relationship therebetween and at least a portion of one of said walls being formed by a puncture-sealing material, and comprising an air-tight, inflatable portion of toroidal-like shape extending around and joined in airtight relationship to said walls, said air passageway opening into the interior of said last-mentioned portion.

References Cited in the file of this patent UNITED STATES PATENTS 15,897 Provines Oct. 14, 1856 1,115,978 Schweinert et al Nov. 3, 1914 1,713,755 Gibson May 21, 1929 1,915,794 Leo-nhardt June 27, 1933 1,969,671 Nelson Aug. 7, 1934 2,607,346 Milcent Aug. 19, 1952 FOREIGN PATENTS 273,350 Germany Apr. 25, 1914 463,330 Germany July 26, 1928 

